Trial · NCT01291108
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
NCT01291108, Phase 2, Completed, Allergan; results first posted 2013-11-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension. Trials, record NCT01291108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01291108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
- NCT number
- NCT01291108
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Glaucoma, Open-Angle, Ocular Hypertension
- Interventions
- AGN-210669, bimatoprost, bimatoprost vehicle
- First posted
- 2011-02-08
- Last updated
- 2013-11-06
- Results first posted
- 2013-11-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Average Eye IOP | Baseline, Day 57 | IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. |
| Secondary | Change From Baseline in Worse Eye IOP | Baseline, Day 57 | IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening). Data are recorded at Hours 0, 4, 8, and 12. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Average Eye IOP | Baseline, Day 57 | Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement | Millimeters of Mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Worse Eye IOP | Baseline, Day 57 | Modified Intent to Treat: all randomized and treated patients who had a baseline and at least 1 post-baseline IOP measurement | Millimeters of Mercury (mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Average Eye IOP | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Baseline - Hour 0 | 26.16 | Standard Deviation 2.169 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Baseline - Hour 0 | 25.98 | Standard Deviation 1.962 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Combined Adjunctives | Baseline - Hour 0 | 26.26 | Standard Deviation 2.446 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Baseline - Hour 4 | 23.91 | Standard Deviation 2.382 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Baseline - Hour 4 | 23.82 | Standard Deviation 2.301 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Combined Adjunctives | Baseline - Hour 4 | 23.85 | Standard Deviation 2.553 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Baseline - Hour 8 | 22.49 | Standard Deviation 1.338 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle | Baseline - Hour 8 | 22.35 | Standard Deviation 2.024 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | Combined Adjunctives | Baseline - Hour 8 | 22.79 | Standard Deviation 2.391 | Millimeters of Mercury (mmHg) |
| Change From Baseline in Average Eye IOP | AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle | Baseline - Hour 12 | 21.48 | Standard Deviation 2.467 | Millimeters of Mercury (mmHg) |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Month 1 (Monotherapy) | STARTED | AGN-210669 | 65 | |
| Month 1 (Monotherapy) | STARTED | AGN-210669 + Bimatoprost | 0 | |
| Month 1 (Monotherapy) | STARTED | AGN-210669 + Bimatoprost Vehicle | 0 | |
| Month 1 (Monotherapy) | STARTED | Bimatoprost | 60 | |
| Month 1 (Monotherapy) | STARTED | Bimatoprost + AGN-210669 | 0 | |
| Month 1 (Monotherapy) | STARTED | Bimatoprost + Bimatoprost Vehicle | 0 | |
| Month 1 (Monotherapy) | COMPLETED | AGN-210669 | 64 | |
| Month 1 (Monotherapy) | COMPLETED | AGN-210669 + Bimatoprost | 0 | |
| Month 1 (Monotherapy) | COMPLETED | AGN-210669 + Bimatoprost Vehicle | 0 | |
| Month 1 (Monotherapy) | COMPLETED | Bimatoprost | 60 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events96
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Corneal Thickening | Eye disorders | AGN-210669 | 19 | 65 | |
| other | Corneal Thickening | Eye disorders | AGN-210669 + Bimatoprost | 10 | 40 | |
| other | Corneal Thickening | Eye disorders | AGN-210669 + Bimatoprost Vehicle | 4 | 24 | |
| other | Corneal Thickening | Eye disorders | Bimatoprost | 2 | 60 | |
| other | Corneal Thickening | Eye disorders | Bimatoprost + AGN-210669 | 15 | 34 | |
| other | Corneal Thickening | Eye disorders | Bimatoprost + Bimatoprost Vehicle | 0 | 26 | |
| other | Conjunctival Hyperaemia | Eye disorders | AGN-210669 | 17 | 65 | |
| other | Conjunctival Hyperaemia | Eye disorders | AGN-210669 + Bimatoprost | 23 | 40 | |
| other | Conjunctival Hyperaemia | Eye disorders | AGN-210669 + Bimatoprost Vehicle | 2 | 24 | |
| other | Conjunctival Hyperaemia | Eye disorders | Bimatoprost | 24 | 60 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AGN-210669 | ||
| Total, all-cause mortality | AGN-210669 + Bimatoprost | ||
| Total, all-cause mortality | AGN-210669 + Bimatoprost Vehicle | ||
| Total, all-cause mortality | Bimatoprost | ||
| Total, all-cause mortality | Bimatoprost + AGN-210669 | ||
| Total, all-cause mortality | Bimatoprost + Bimatoprost Vehicle | ||
| Total, other adverse events | AGN-210669 | 43 | 65 |
| Total, other adverse events | AGN-210669 + Bimatoprost | 31 | 40 |
| Total, other adverse events | AGN-210669 + Bimatoprost Vehicle | 11 | 24 |
| Total, other adverse events | Bimatoprost | 41 | 60 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01291108
GET https://conductscience.org/api/trials/v1/NCT01291108/results?page=2